Trials / Terminated
TerminatedNCT04065841
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 234 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
Detailed description
The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. The study duration from first dose of study medication was 52 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tropifexor | 100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day |
| DRUG | Licogliflozin | 30mg tablet of licoglifozin taken orally every day |
| OTHER | Placebo | licogliflozin placebo + tropifexor placebo |
Timeline
- Start date
- 2019-12-30
- Primary completion
- 2022-10-27
- Completion
- 2022-10-27
- First posted
- 2019-08-22
- Last updated
- 2025-01-28
- Results posted
- 2023-12-26
Locations
80 sites across 24 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Denmark, Estonia, Germany, India, Italy, Japan, Mexico, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04065841. Inclusion in this directory is not an endorsement.